Is the issue truly a need for "concrete rules" or just an apparent selective enforcement of the rules leading one to believe that compliance is not really mandated? Selective enforcement would arise as there is perhaps absolutely no way to monitor everything. Taking advantage of this will only harm the industry as the good ole govment may find ways to narrow the industry so that monitoring is manageable. This may happen if numbskulls keep spiking products with meth, steroids, PHs, or distributing products causing actual harm to people.

Candidly, I think you guys know what is expected of you and you could easily hire a lawyer to advise you what is expected if you had questions . . . or you could pick up the phone and call the agency if you had questions to ensure compliance. I would do the latter if I was advising a client as to a grey area because I think human safety is more important that corporate greed.

Candidly, I think you guys know what is expected of you and you could easily hire a lawyer to advise you what is expected if you had questions . . . or you could pick up the phone and call the agency if you had questions to ensure compliance. I would do the latter if I was advising a client as to a grey area because I think human safety is more important that corporate greed.

Do you understand the process to make that candid statement? you can easily make the same "lawyer" call and then have a better understanding of the process and why companies don't seek it.

I would gladly go through the process but there is no clear process and that is what industry is calling for (you could easily spend in the 7 figures and have an ingredient rejected).... but Aegeline was clearly in the food supply pre 1994.

You are 110% wrong, Huperzine A is an ingredient was rejected as an NDI. The metabolite has to be in the food supply. You have couple supplements and several ingredients non compliant.

So was isopropyl octopamine. It's just a matter of time. It's unfortunate you are on the hit list.

Is the issue truly a need for "concrete rules" or just an apparent selective enforcement of the rules leading one to believe that compliance is not really mandated? Selective enforcement would arise as there is perhaps absolutely no way to monitor everything. Taking advantage of this will only harm the industry as the good ole govment may find ways to narrow the industry so that monitoring is manageable. This may happen if numbskulls keep spiking products with meth, steroids, PHs, or distributing products causing actual harm to people.

Candidly, I think you guys know what is expected of you and you could easily hire a lawyer to advise you what is expected if you had questions . . . or you could pick up the phone and call the agency if you had questions to ensure compliance. I would do the latter if I was advising a client as to a grey area because I think human safety is more important that corporate greed.

Actually he has a point here. A lot of the FDAs bullet points on their lists of goals each year involve figuring out how they even want to interpret their own regulations.

The FDA openly admits that many of their regulations are not clear.

In their attempt to clarify NDI requirements with their draft guidance a couple of years ago they produced a 40 page list of 'guidelines' for how to interpret it. I'm guessing the revision to those guidelines that is coming next year will be even longer.

As of right now, there is effectively no way to submit an NDI and be assured of acknowledgement, regardless of how much effort you put into it.

Actually he has a point here. A lot of the FDAs bullet points on their lists of goals each year involve figuring out how they even want to interpret their own regulations.

The FDA openly admits that many of their regulations are not clear.

In their attempt to clarify NDI requirements with their draft guidance a couple of years ago they produced a 40 page list of 'guidelines' for how to interpret it. I'm guessing the revision to those guidelines that is coming next year will be even longer.

As of right now, there is effectively no way to submit an NDI and be assured of acknowledgement, regardless of how much effort you put into it.

I have no doubt. Sounds about right for most government branches that regulate anything, but you even pointed out what could have or should have been done with the aegeline.

40 pages of definitions or explanations is actually light reading compared to the industries in which I primarily practice: health care; pharmacy industry; medical device and securities.

The problem is all of the mislabeled and contaminated crap we get in the supplement industry. I am not necessarily talking about you guys. There has been some recent articles noting 59% of all supps contaminated and 1/3 having no trace of the alleged main ingredient.

I see this as a serious problem and find it disingenuous to place the blame on the FDA for issues like those below.

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ConsumerLab.com purchased and tested more than 50 human and pet osteoarthritis supplements containing glucosamine, chondroitin, and MSM and found some of the products to be contaminated with lead, missing certain listed ingredients, or have inadequate labeling.
One-third of people who take multiple dietary supplements take a joint health supplement according to the latest ConsumerLab.com consumer survey.

The study specifically found the following:
•59 percent of the products tested contained species of plants not listed on the labels (fillers and contaminants).
•33 percent of the products contained no trace of the product’s main labeled ingredient.

Only 2 of the 12 companies provided authentic products without any unlabeled substitutions, fillers and contaminants.